Independent Surgical Center

ABSTRACT

A biological tissue cutting and fluid aspiration system provides a plurality of surgical instruments operable independent of an external control console. In some embodiments, each surgical instrument may include all sensors and controls directly applicable to the surgical instrument, and may be used independently. In some embodiments, instruments communicate status information to each other, and adjust operating parameters based on the communications.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims the benefit of U.S. Provisional Application No.60/925,546, filed on Apr. 20, 2007, the content of which is incorporatedherein by reference. This application is also related to U.S.Application entitled “Surgical Pack and Tray” (attorney docketD614-61714), and U.S. Application entitled “Personal Surgical Center”(attorney docket D614-61713), both filed on even date herewith, thecontent of both of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to surgical systems, and moreparticularly to a surgical system including instrumentation that isoperable without an external control console.

BACKGROUND OF THE INVENTION

Innovations in medical surgery have allowed many to recover fromailments previously thought untreatable or incurable. For example,various ophthalmic surgical procedures have been developed which repairportions of the human eye, including internal components of the eye, torelieve different visual ailments. As medical surgery develops andexpands into new areas of the human body, often with limitedaccessibility, more complex surgical instrumentation is developed.Furthermore, the more complex the surgical instrumentation, generallythe greater demand there is for precision of the surgicalinstrumentation.

To increase precision and accuracy in surgical procedures, controlconsoles are often integrated into surgical systems. Control consolesmay be used, for example, to adjust the control parameters of thevarious surgical instruments being used, to monitor the status of thesurgical instruments, and to perform rapid calculations and providefeedback to doctors and other medical personnel to assist in determininghow to proceed with the surgical procedure. Ophthalmic surgicalprocedures are no different. For example, a vitrectomy, which involvesthe surgical removal of fluid within the eye, is generally performedusing instrumentation driven by a computer system housed in a largecontrol console. The control console is generally stationary or housedin a large rolling unit outside the sterile barrier, and includes devicemodules which directly connect to the surgical instrumentation. With thecontrol console located outside the sterile barrier, the surgeon orother qualified practitioner operates the instrumentation at the patientlevel, while at least one other medical personnel operates the controlsat the control console at the direction of the surgeon.

SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to an independentlyoperable surgical system for conducting surgeries and medicalprocedures, such as, for example, vitrectomies and other ophthalmicsurgical procedures.

According to one embodiment of the invention, an independent system fora surgical procedure is comprised of a control device including aprocessing unit; and a plurality of instruments associated with thesurgical procedure and operably coupled to the control device, whereinthe control device and the plurality of instruments are prepackagedtogether, and the processing unit is configured to control at least oneof the prepackaged instruments. The instruments may be electricalinstruments.

According to another embodiment of the invention, a surgical system iscomprised of a portable surgical tray including a processing unit; aplurality of instruments operably coupled to the processing unit; and auser input device providing a user input for controlling an operatingparameter of one or more of the plurality of instruments, wherein theprocessing unit is configured to receive the user input and transmit anoperating command to the one or more of the plurality of instruments.

In yet another embodiment of the invention, a self-powered surgicalsystem for a surgical procedure is comprised of a surgical tray; aplurality of handheld instruments; a power source in at least one of thesurgical tray and a handheld instrument; and a processing unit, whereinthe processing unit is configured to execute program instructions, theprogram instructions including instructions for: detecting power fromthe at least one power source; directing power to the plurality ofhandheld instruments from at least one power source; and establishingcommunication with each of the plurality of handheld instruments.

According to one embodiment, a portable biological cutting andaspiration device includes: a cutting tip; a fluid aspiration device;and an integrated control unit coupled to the cutting tip and fluidaspiration device, wherein the control unit is configured to controlcutting and aspiration of the cutting tip and fluid aspiration device.

According to one embodiment, a portable infusion and aspiration deviceincludes: an aspiration chamber; an aspiration line coupled to abiological tissue cutting and aspiration device, the aspiration lineconfigured to suction matter dislodged from a surgical site into theaspiration chamber; an infusion chamber having an infusion solution; aninfusion line coupled to the infusion chamber and configured to injectthe infusion solution to the surgical site for maintaining pressure inthe surgical site, wherein the aspiration chamber and infusion chamberare included in a single, disposable cassette.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of various instruments inserted into the eyein the course of performing a vitrectomy;

FIG. 2 a is a block diagram of a surgical system including anindependent surgical center 10 according to one embodiment of theinvention;

FIG. 2 b is a schematic illustration of an independent surgical centerembodied as a surgical tray in accordance with one embodiment of theinvention;

FIG. 3 is a block diagram of the internal components of an independentsurgical center in accordance with one embodiment of the invention;

FIG. 4 is a flow diagram of an initialization and communicationestablishment process for an independent surgical center in accordancewith one embodiment of the invention;

FIG. 5 is a block diagram of an independent surgical center embodied asa surgical tray in communication with a handpiece in accordance with oneembodiment of the invention;

FIG. 6 is a flow diagram of a process executed by the processing unit ofthe independent surgical center in accordance with one embodiment of theinvention;

FIG. 7 is an alternate embodiment of an independent surgical center inaccordance with aspects of the invention;

FIG. 8 is a block diagram of an independent surgical center embodied asthe infusion/aspiration cartridge in accordance with one embodiment ofthe invention; and

FIG. 9 is a block diagram of yet another alternate embodiment of anindependent surgical center in accordance with one embodiment of theinvention.

DETAILED DESCRIPTION

FIG. 1 is a block diagram of various instruments inserted into the eyein the course of performing a vitrectomy. Vitreous is a normally clear,gel-like substance that fills the center of the eye, for example, eye101. In some instances, blood, debris, or scar tissue may collect in thevitreous, partially or fully obstructing vision. In these instances, avitrectomy, or surgical removal of all or a part of the eye's vitreous,may be performed.

To perform a vitrectomy, a number of incisions are made into the sclera103, the white portion of the eye. Various instruments access the centerof the eye through the incisions. The inserted instruments in FIG. 1include a handheld biological tissue cutter and fluid aspiration tool(“handpiece”) 105, an illumination device 107, and an infusion device109. The handpiece includes a biological tissue cutter for cutting ordislodging portions of the eye's vitreous, as well as an aspirator forremoval of the cut or dislodged portions. The infusion device is used toreplace fluid and maintain proper pressure in the eye. The illuminationdevice is used as a light source to see into the center of the eyeduring the procedure.

The present invention is directed to an independent surgical systemoperable without the use of an external surgical console. In someembodiments, for example, a modular surgical system consists ofindependent surgical instrumentation. The surgical instrumentation mayinclude, for example, a series of interlinked handheld instruments, suchas the cutting handpiece and the illumination device. In someembodiments, the individual instruments contain self-sustainingoperating intelligence and are not dependent on commands from a controlsource, providing a surgeon or other medical practitioner with full andindependent control of each individual instrument within a sterilefield.

Although the independent surgical center is described herein mainly inconnection with vitrectomy procedures, a person of skill in the artshould recognize that the center may also be configured for othermedical procedures performed on all tissue including the eye or otherparts of the human body. For example, phacoemulsification involves theremoval of a lens of an eye using a similar handpiece including anultrasonic cutter and an aspirator. For various other applications,instruments may include, for example, different cutters, vacuumingdevices, irrigation devices, viewing devices, and/or illuminationdevices, among others. According to one embodiment of the invention,most, if not all, of the instruments of a particular system contain thecircuitry and power to control and operate themselves independently ofeach other. In some embodiments, the instruments may communicate witheach other via a wireless connection, and one instrument may act as amain processing or control unit. Therefore, while the description mayoften refer to details of embodiments of the invention configured for avitrectomy, the description is not intended to represent the onlyapplication in which the invention may be utilized. While differentprocedures may involve slightly different embodiments, it is to beunderstood that equivalent functions and structures may be realized bythe different embodiments that are also intended to be encompassedwithin the spirit and scope of the invention.

FIG. 2 a is a block diagram of a surgical system including anindependent surgical center 10 according to one embodiment of theinvention. The independent surgical center 10 acts as a control devicefor the surgical system and is operably coupled to one or more medicalinstruments, such as, for example, one or more viewing devices 12,infusion devices 14, irrigation devices 16, illumination devices 18, andcutting devices 20, over wired or wireless connections 24 f, 24 e, 24 d,24 c, 24 b. The independent surgical center 10 is also operably coupledto other devices 22 over wired or wireless connection 24 a. Such otherdevices may include, but are not limited to, foot pedals, secondarydisplay screens, audio outputs, and the like.

According to one embodiment of the invention, the independent surgicalcenter 10 is further optionally coupled to a personal surgical centerover connection 24 g. Preferably, connection 24 g is a wirelessconnection, although the connection may alternatively take the form of awired connection. As described in detail in U.S. Application entitledPersonal Surgical Center filed on even date herewith, the personalsurgical center 26 is configured to monitor the settings of the variousmedical instruments while the actual control of the medical instrumentsis via the independent surgical center 10 and/or via logic and circuitryincluded in the medical instrument themselves. In this regard, theindependent surgical center 10 and medical instruments 12-20 are locatedwithin the sterile field in which a surgery is performed, while thepersonal surgical center 26 is located outside the sterile field. Inthis manner, the surgeon has direct access and control of theindependent surgical center 10 and instruments during surgery.

The various connections 24 a-24 g from the independent surgical center10 may be wired or wireless. A wireless connection may be, withoutlimitation, a wireless local area connection, such as, for example, an802.11 connection, a personal area network connection such as, forexample, Bluetooth, or any other radio or cellular connectionconventional in the art. A wired connection may be, for example, aserial bus, parallel bus, Ethernet connection, or the like. For example,connection 24 b between the cutting device 20 and the independentsurgical center 10 may be a wired connection. In addition, infusion andaspiration lines may connect the infusion device and irrigation deviceto the independent surgical center 10 and/or the cutting device 20.

The independent surgical center 10 includes the circuitry, power, andlogic to drive and control one or more of the medical instruments.According to one embodiment of the invention, the independent surgicalcenter 10 is embodied as a surgical tray. According to anotherembodiment of the invention, the independent surgical center is embodiedas a particular medical instrumentation such as, for example, aninfusion/aspiration cassette. According to this latter embodiment, theparticular medical instrumentation not only has the logic and circuitryto control itself, but also acts as a control center to control thefunctionality of some or all of the other instruments.

FIG. 2 b is a schematic illustration of an independent surgical centerembodied as a surgical tray in accordance with one embodiment of theinvention. In the embodiment illustrated in FIG. 2, the surgical tray201 houses and controls various medical instruments which may beassociated with different surgery procedures. In some embodiments, thesurgical tray of FIG. 2 provides a sterile environment for packaging ofthe individual instruments before, and in some instances after, aprocedure is performed. In some embodiments, the tray, and theinstruments held in the tray, are designed to be discarded after asingle use.

In the embodiment illustrated in FIG. 2 b, the tray houses variousremovable handheld instruments and surgical supplies, including ahandpiece 203, an infusion line 205, an illumination device 207, aspeculum 209, a syringe 211, cannulas 213, q-tips 215, and a supply ofartificial tears 217. The tray also houses a cartridge including anaspiration chamber 219, an infusion chamber 221, and a pump or similardevice for each respective chamber. In the embodiment illustrated inFIG. 2 b, the handpiece is coupled to the aspiration chamber 219 viaaspiration line 210, and to the infusion chamber 221 over the infusionline 205.

According to one embodiment of the invention, the tray is in wired orwireless communication with one or more pieces of surgicalinstrumentation housed in the tray that require power or control fromthe tray. The tray may also be in wireless communication with otherdevices not housed in the tray, for example, a foot pedal, and/or anexternal monitor. The tray may act as a communication medium betweeneach of the instruments of the surgical system. In embodiments where thetray communicates with an external monitor, the entire system generallyremains independently operable, with the monitor typically serving onlyin a data collection, display and storage capacity.

According to one embodiment of the invention, the various medicalinstruments, including the tray, are designed to be portable,lightweight, and inexpensive. In some embodiments, the tray includesinternal circuitry and various components for controlling the variousmedical instruments. Internal components may include, for example, aprocessing unit, user controls, a power source, and a plurality ofdifferent interfacing devices. The processing unit may be, for example,a microprocessor based unit, and ASIC, or the like. The interfacingdevices may include, for example, a wireless communication interface tocommunicate with the other instruments of the surgical system. The powersource, for example, a battery, allows the tray to be independentlypowered, and in some embodiments, provide power to devices connected tothe tray, such as the handpiece. In some embodiments, the tray may alsoinclude a display or speaker, which may output various status indicatorsor settings of connected instruments.

In some embodiments, the tray is designed for a single use, and theinstruments of the tray are prepackaged together in sterile packaging.In these embodiments, the packaging may be opened, and the tray and thecomponents within the tray, activated, within a sterile operating fieldjust prior to performing the surgical procedure. This gives a medicalpractitioner access to and control of all the applicable surgicalinstrumentation within the sterile field, including any instrumentcontrols and status indicators located on the tray. In some embodiments,upon activation, the tray may perform an initial scan or similarinformation retrieval process, to determine the available devices orinstruments with which it may communicate during the procedure. The traymay establish lines of communication, generally wirelessly, with thevarious different instruments of the tray.

According to one embodiment of the invention, the tray is connected tothe handpiece 203 and the infusion line 205. In biological tissuecutting applications, the handpiece may include a biological tissuecutter, and may be connected to the tray via the fluid aspiration line210. In operation, the cutter cuts or dislodges biological tissue, andthe aspiration line suctions the dislodged tissue, where it is collectedin the isolated aspiration chamber 219. The infusion line 205 may beused to inject the surgical site with fluid or gaseous solutions orother materials to replace the aspirated tissue. For example, invitrectomies, pressure is maintained within the eye through infusion ofbalanced salt solution to replace the aspirated vitreous. Infusionfluids may be held in an infusion chamber of the tray, or alternativelyin a sealed infusion bag or pouch held in the infusion chamber, andinfused into a patient through the infusion line at a rate determined bycontrols located on the tray. According to one embodiment of theinvention, both the aspiration chamber 219 and infusion chamber 221reside in a single disposable cassette.

In some embodiments, operating parameters for the different instruments,for example, cut speed, aspiration pressure, infusion rate, andillumination level, may be controlled directly through the individualdevices used to perform each respective function. For example, thehandpiece may include controls for controlling the cut speed and theaspiration pressure, providing a surgeon more direct control over theprocedure. Alternatively, input devices coupled to the tray be used tocontrol the parameters of one or more of the medical instruments. Anexemplary input device is a foot pedal wirelessly connected to the tray.A surgeon may use the foot pedal to control, for example, the cut speedand aspiration pressure. The tray receives the changes to the cut speedand/or aspiration pressure, and in turn controls the handpiece based onthe received input. Similarly, the illumination level may be controlleddirectly on the illumination device, and the infusion rate may becontrolled either by controls located on the infusion line or on thetray. A person of skill in the art should recognize that other inputdevices such as knobs, switches, and/or buttons may be used for controlinput in addition or in lieu of the foot pedal.

The tray may also communicate with the various instruments to retrievestatus information, for example, instrument settings, current operatingparameters, and fault conditions, from the various instruments. Forexample, while the illumination device is wholly separable from thetray, and may function and be controlled independently of the tray, thetray may nevertheless receive information on the current illuminationlevel and communicate that information to the surgeon or practitioner.According to one embodiment of the invention, the tray forwards themonitored information to the personal surgical center 26 over datacommunications link 24 g. In some embodiments, information may bedisplayed on a built-in display mounted on the tray. In otherembodiments, other output or user feedback means may be incorporated,for example, a series of LEDs indicating current parameter or statusinformation of the various instruments.

FIG. 3 is a block diagram of the internal components of an independentsurgical center 10 in accordance with one embodiment of the invention.According to the illustrated embodiment, the independent surgical center10 includes a processing unit 301 connected and in communication with awireless communication interface 303, a status indicator such as amonitor or collection of LEDs 305, an aspiration device 307, an infusiondevice 309, a plurality of user controls or other input devices 311, andother components or circuitry 313. A power source 315 may also beconnected to the various components, and provides power to run the othercomponents. The infusion device may be further connected to a supply ofinfusion fluid or gas 317, for example, a reservoir of balanced saltsolution.

The processing unit 301 facilitates operation of one or more instrumentsby sending control commands to those instruments, and acts as aninformation resource by collecting current parameter settings and otherstatus information from the same or other instruments of the surgicalsystem. In some embodiments, status information is collected from all ofthe connected instruments and communicated by the tray to a surgeon orother user of the surgical system, as well as optionally to the personalsurgical center 26.

The processing unit 301 may control the medical instruments based onuser requests. In some instances, the requests may come from usercontrols located on the independent surgical center itself, in the formof, for example, buttons or adjustable dials. In other instances, usercontrols may be received from connected devices, for example, thehandpiece or the infusion line as illustrated in FIG. 2 b. In stillother instances, control or adjustment requests may be received fromremote instruments of the surgical system, for example, the illuminationdevice 18, or for example, a foot pedal, via the wireless communicationinterface 303.

The processing unit 301 processes the user requests and generatescommand signals to send to the instruments or devices for which theadjustments were intended. In some embodiments, the independent surgicalcenter 10 may be configured to direct or control the operation ofparticular devices in the surgical system. For example, in theembodiment of the tray as the independent surgical center, the tray maybe limited to controlling devices located on or within the tray itself,such as, for example, the aspiration device 307 and the infusion device309. In some other embodiments, the processing unit 301 may serve as acentral control unit for the various instruments and devices in thesurgical system, and may receive all the instrument adjustment requestsand send associated control commands to the appropriate devices in thesystem.

In operation, a user request may be received from a first device, forexample, the handpiece, and be intended for adjusting a second device,for example, the aspiration device. The processing unit 301 may directlyadjust the control parameters of the aspiration device, which may be,for example, a centrifugal pump, a venturi pump, a peristaltic pump, orany suitable vacuum based system, or may alternatively be a motorcontrolling a syringe or piston to apply vacuum pressure. Similaradjustments may be made to a connected infusion device, which may be,for example, a general disposable pump, peristaltic pump, a Harvardapparatus syringe pump, a spring loaded syringe, or an IV pole. In someembodiments, a supply of infusion solution is prepackaged with thesystem, the solution being appropriate for the particular applicationfor which the system is intended. In vitrectomy procedures, theprepackaged solution may be sterile balanced salt solution. If a pump isused, it may pressurize the infusion chamber holding the balanced saltsolution, causing the solution to enter the eye. Alternatively, aseparately sealed infusion bag holding the balanced salt solution may behoused by the infusion chamber and connected to the infusion line. Thepressure level of the infusion chamber may be increased, compressing theinfusion bag, and forcing the balanced salt solution out of the infusionbag to the eye.

Some surgical procedures may involve gas exchange, or a combination ofliquid and gas exchange. In some embodiments of the invention, theinfusion device 309 may provide for multiple infusion sources, and holdvarious types of liquids and gases for infusion. In these embodiments,the independent surgical center 10 may also include a control whichdetermines the infusion source being applied in the surgical procedure.For example, for a surgical system including an infusion source with aliquid solution and an infusion source with an air fluid or gaseousmatter, the independent surgical center 10 may provide for a control toselect between liquid solution exchange or air fluid exchange.

According to one embodiment of the invention, the independent surgicalcenter also provides feedback to users in the form of setting monitorsand status indicators. The processing unit 301 receives statusinformation from the plurality of connected instruments, typicallyperformed through data communication lines for connected instruments, orthrough the wireless communication interface for remote instruments. Theprocessing unit compiles the information and communicates theinformation to the surgeon or other user. According to one embodiment ofthe invention, the independent surgical center may include a smallmonitor or screen for displaying information about the surgicalprocedure or the instrumentation. In addition to, or in lieu of, amonitor, optical LEDs and/or audio speakers may be provided to generatestatus outputs or alerts for various system events.

FIG. 4 is a flow diagram of an initialization and communicationestablishment process for an independent surgical center in accordancewith one embodiment of the invention. The process may be implemented ascomputer program instructions stored in memory (not shown) and invokedby the processing unit 301. In some embodiments, the process of FIG. 4is performed when the system is initialized. In block 411, the processactivates or begins supplying power to the processing unit 301. In someembodiments, the independent surgical center 10 housing the processingunit also houses the power source 315 to supply power to the processingunit. Some embodiments may involve plugging the system into an externalpower source, for example, an electrical outlet. However, embodimentsincluding an internal power source, for example, a battery, generallyprovide for better maneuverability. In embodiments where the powersource is housed in the tray of the system, the power source may alsopower the aspiration and infusion devices 307, 309, and may providepower to a connected handpiece as well. In some embodiments where theindependent surgical center 10 is embodied as the surgical tray, powerto the independent surgical center 10 is activated once the tray isopened or removed from its packaging, through an automated switchactivation or similar mechanism. The processing unit detects power fromthe power source and activates the system. In other embodiments, anadditional user-controlled switch or control device may be provided tomanually activate the power supply.

In block 413, the process detects one or more devices or instrumentswhich may be utilized during a procedure in which the independentsurgical center is used. In this regard, the process invokes thewireless communication interface 303, such as, for example, a radiofrequency identification (RFID) reader, and automatically interrogatesone or more identification tags, such as, for example, an RFID, tagcoupled to the one or more devices or instruments or to packagingholding individual or multiple ones of the devices or instruments. TheRFID tag transmits identification information (e.g. device ID or modelnumber) as well as specific information on the individual instruments,for example, instrument types, configuration parameters, and availablepower settings. In some embodiments, some instruments may be included insurgical packages including specific surgical instrumentation associatedwith a particular procedure. In this embodiment, the packages mayinclude RFID systems that identify the instruments in the package, oralternatively, each of the available instruments may include a separateRFID tag, so that communication may more readily be established witheach of the individual devices. In some embodiments, for example, theembodiments described with respect to FIG. 2 a, the surgical tray mayinclude instruments which may be used for various different procedures.In these embodiments, the system may be configured to provide forselection of a desired procedure, and the tray may identify eachavailable instrument to determine whether each instrument is to be usedfor the desired procedure.

In block 415, the process establishes communication with the one or moreidentified devices. The communication may then be used to controloperation of the identified devices and/or to receive status informationfrom the identified devices. According to one embodiment of theinvention, wireless communication may not need to be established withall identified devices. For example, the process may be configured toselect the instruments which are to be used in a particular procedure inresponse to a user command, and establish wireless links with thoseinstruments, rather than with all the available instruments. In someembodiments, the processing unit first directs a power source to supplypower to a selected instrument before communication may be establishedbetween the processing unit and the selected instrument.

In block 417, the process sends initial configuration settings to thedevices with which communication has been established. Wireless datareceived from the various connected instruments may be used to, forexample, pull up and configure the appropriate setup or monitoringscreens on the independent surgical center itself, an external statusmonitor coupled to the independent surgical center, and/or on thepersonal surgical center. In some embodiments, the wireless connectionmay also be used to relay initial surgical settings and instrument faultparameters to one or more of the individual instruments. In someembodiments, each independent surgical center may be pre-configured toperform a specific procedure, and the processing unit 301 may sendinitial configuration settings to the one or more instruments based onthe pre-configurations for a particular procedure. In some embodiments,the personal surgical center may invoke the user controls 311 reading orinputting user preferences or patient data or statistics. In theseembodiments, initial configuration settings may instead be based on moreuser-specific or patient-specific information provided via the usercontrols.

FIG. 5 is a block diagram of an independent surgical center embodied asa surgical tray 505 in communication with a handpiece 503 in accordancewith one embodiment of the invention. According to this embodiment, thehandpiece is a biological tissue cutting and fluid aspiration system. Anaspiration line or tube 501 connects the handpiece 503 to the tray 505for suctioning unwanted materials from a surgery site. In this regard,the tray includes an aspiration chamber and an aspiration device 507,for example, a pump or vacuum. In these embodiments, the aspirationdevice provides suction or vacuum to the handpiece through theaspiration line 501, and a reservoir or like chamber is provided forcollection of materials aspirated through the line or tube. Theaspiration chamber may be similar to the aspiration chamber 219 of FIG.2 b.

In alternative embodiments, the aspirating handpiece may be configuredwith an internal pump and collection chamber. According to thesealternative embodiments, the aspiration line 501 would no longer benecessary, and the connection between the handpiece and the tray wouldbe completely wireless.

In the embodiment illustrated in FIG. 5, in addition to the aspirationdevice 507, the tray includes a processing unit 509, a power source 511,an infusion device 513, a wireless transceiver 515, and statusindicators 517. The processing unit 509, power source 511, infusiondevice 513, wireless transceiver 515, and status indicators 517 may besimilar to the processing unit 301, power source 315, infusion device309, wireless communication interface 303, and monitor/LEDs 305described with respect to FIG. 3. The handpiece 503 includes abiological tissue cutter 519 and a set of user controls 521. In variousembodiments of the invention, the components in the tray and thehandpiece may be arranged differently. There may also be differentcombinations of components, including various components not included inFIG. 5, which may be included in other embodiments of the invention,depending on the application of each respective system.

The user controls 521 included in the handpiece may, for example,control the cut speed of the cutter on the handpiece, or for example,the aspiration level of the aspiration device, located on the tray, orboth. Generally, user controls associated with a particular instrumentor component of the system are located on that particular instrument orcomponent, providing intuitive device-control associations and easieraccess to users of the system. The user controls on the handpiece may beconnected to and operate in accordance with the processing unit 509. Thehandpiece may also receive additional instructions or operationparameters, for example, a maximum permissible cut speed from theprocessing unit. The cutter 519 may communicate with the processing unitas well, for example, for relaying status information on the current cutspeed. Furthermore, the power source 511 FIG. 5 is housed in the tray,providing power to the components of the tray. An electrical line 523may be tethered from the tray to the handpiece, to facilitatecommunication between the handpiece and the tray, as well as supplyingpower to the components of the handpiece.

The aspiration device 507 housed on the tray may be one of variousdifferent aspirating instruments, for example, a centrifugal pump, or analternate suitable vacuum based system. Some embodiments of theinvention may provide controls for the aspiration device on thehandpiece, while other embodiments may instead provide controls for theaspiration device on the tray. Still other embodiments of the inventionmay provide controls for the aspiration device on another instrument,for example, a foot pedal, in wireless (or wired) communication with thetray. The processing unit 509 retrieves aspiration adjustment requestsfrom one of the various controls, and applies the adjustments to theaspiration device 507. The adjustments may cause the aspiration rate ofthe aspiration line, and consequently the aspiration rate of thehandpiece, to fluctuate.

The infusion device 513 housed on the tray is typically connected to anoutgoing infusion line (not shown). The infusion device may be one ofvarious different infusion instruments, for example, a Harvard Apparatussyringe pump, or for example, a spring loaded syringe. The infusiondevice supplies different fluids or gases to a surgical site through theinfusion line, the particular fluid or gas dependent on the particularsurgical procedure being performed. In vitrectomies, for example, asterile balanced salt solution is provided to the eye by the infusiondevice. In some embodiments, the infusion rate of the infusion devicemay be controlled by the processing unit 509 of the tray based on, forexample, the rate of aspiration. In some applications, the infusion ratemay be in synchrony with the aspiration rate, to maintain a constantpressure or a constant volume at the surgical site. In otherembodiments, the tray may provide an independent set of user controlsfor the infusion rate, whereby the infusion rate may be adjustedindependent of the aspiration rate.

In the embodiment of FIG. 5, the tray also wirelessly communicates withthe other instruments in the surgical system through the wirelesstransceiver 515. In this embodiment, the tray may act as a controldevice and may be used to control the functionality of some or all ofthe other instruments. For example, for a vitrectomy procedure, possiblewirelessly connected devices may include, an illumination device, a footpedal, and an external monitor. In some instances, the connected devicesmay be used to control certain aspects of the system. For example, thefoot pedal may provide an alternate mechanism to control the cut speedand the aspiration level of the system. In these instances, the footpedal may wirelessly send adjustment commands to the tray, where theprocessing unit routes the adjustment commands to the appropriatedestination.

In other instances, one or more of the instruments used to perform thesurgical procedure are independently controlled and operated, and usercontrols for each respective instrument may be provided directly on theinstrument. For example, the illumination device may be a portable,self-powered, handheld LED illuminating instrument or comparableilluminating device. Similarly to the cutter controls being provided onthe handpiece, illumination controls may be provided directly on theilluminating device to control operating parameters, such as lightintensity of the provided illumination. In these instances, thewirelessly connected instruments may still transmit useful statistics,current settings, or status information on the surgical procedure to thetray 505. The tray may further include a display, speakers, or otherstatus indicators 517, for communicating the information to a user ofthe system. In some embodiments, an external monitor may also bewirelessly connected to the tray, and used to store compiled informationon the surgical procedure. The various instruments may also communicatewirelessly with the tray, as well as with each other, to optimizeoperating parameters.

FIG. 6 is a flow diagram of a process executed by the processing unit509, 301 of the independent surgical center in accordance with oneembodiment of the invention. In some embodiments, the process of FIG. 6represents the process which is performed by the processing unit housedin the tray in FIG. 5. In some embodiments of the invention, the processmay be performed in another instrument or component of the system, basedon where the processing unit is located in the system. In someembodiments, the system may include multiple processing units, and theprocess of FIG. 6 may be performed by one or more of the multipleprocessing units.

In block 611, the process receives a signal from an instrument incommunication with the independent surgical center. In the embodimentillustrated in FIG. 5, the tray 505 may receive the signals from aninstrument through a wired connection, for example, the handpiece 503 asillustrated in FIG. 5, or may receive the signals from an instrumentthrough a wireless connection, for example, from the illuminationdevice.

In block 613, the process determines whether the received signal is astatus update signal or an adjustment request signal. In someembodiments, the processing unit 509, 301 may be used to adjustoperation parameters of selected instruments, and may also be used toprocess and communicate to a user the status of the same or otherinstruments. If the processing unit determines that the signal is anadjustment request signal, the process proceeds to block 615. If theprocessing unit determines that the signal is a status update signal,the process instead proceeds to block 619.

In block 615, the process determines the device for which the adjustmentsignal is directed. In some embodiments, the adjustment signal may bereceived by a user control directly connected to the processing unit.For example, in the embodiment of FIG. 5, the adjustment signal mayoriginate from a user control controlling the infusion device locatedalongside the processing unit in the tray. In other embodiments, theadjustment signal may be received wirelessly from a user control locatedon a remote instrument, for example, a foot pedal associated with thetray. Some of the adjustment requests may be meant for the device orcomponent from which the signal originated, while some other of theadjustment requests may be meant for a different device, whether it be adevice on the tray or on a completely separate instrument in thesurgical system. Regardless of the source of the adjustment signal, theprocessing unit determines the intended destination device orinstrument.

In block 617, the process sends an adjustment command to the destinationdevice or instrument. Depending on the configuration of the system, theadjustment command may be an unaltered adjustment signal, where theprocessing unit acts as a switch or routing device for the system, orthe adjustment command may be a wholly new command signal generated bythe processing unit based on a received adjustment request signal, forexample, a received signal as was described above with respect to block611. In most embodiments of the system, after an adjustment command issent to a respective device or instrument, the operational settings orparameters of the device are adjusted in accordance with the adjustmentcommand.

If the signal is a status update signal, the process, in block 619,determines the source of the status update signal. In most embodiments,status update signals include status update information of the devicefrom which the status update signal originated. The status updateinformation may include various information about an originating device,for example, current settings, operating parameters, remaining powerlevels, instrument fault conditions, and other information. Statusinformation for each specific instrument in the system is differentdepending on the functionality of the instrument. For example, ahandpiece may provide status of cut speed of a cutter or aspirationlevels, whereas an illumination device may provide illumination levelstatus.

In block 621, the process updates the status of a device or instrument.Whether the originally received signal was an adjustment signal or astatus update signal, the processing unit of the system may updatestatus information pertaining to the received signal. In cases where thesignal was an adjustment signal, the processing unit may update thestatus information of the destination device to which the adjustmentrequest was sent. In cases where the signal was a status update signal,the processor may directly update the status information of the devicefrom which the status update signal originated, based on the contents ofthe status update signal. The processing unit may display the statusupdates on, for example, a monitor located on the instrument housing theprocessing unit. Alternatively, the status updates may be expressedvisually through changes to, for example, LED indicators, or aurallythrough, for example, audio alerts outputted through available speakers.In some embodiments, visual or aural status indicators may be availableon various other instruments of the system in addition to, or in lieuof, the instrument housing the processing unit. In these embodiments,the processing unit may send the status update information to anappropriate instrument for output or user feedback purposes. Accordingto one embodiment of the invention, the update information istransmitted to the personal surgical center for logging in a log filegenerated for the surgical procedure. After the status updates have beenapplied to or recorded by the system, the process returns.

FIG. 7 is an alternate embodiment of an independent surgical center inaccordance with aspects of the invention. The center illustrated in FIG.7 is operable independently of an external console, and functionssimilarly to the system described with respect to FIG. 2 b. However, thesystem of FIG. 7 does not include a tray which acts as a central controlunit. Instead, in FIG. 7, the system includes a stand-aloneaspiration/infusion cartridge 701, including isolated aspiration 703 andinfusion chambers 705, and a separate device for each chamber, forexample, an aspiration pump or similar device 707 and an infusion pumpor similar device 709. The cartridge is connected to a handpiece 711 andan infusion line 713.

According to the illustrated embodiment, the cartridge 701 as a centralcontrol unit instead of the tray as in FIG. 2 b. The cartridge is incommunication with other surgical instrumentations of the surgicalsystem. The communication is generally established through wirelessconnections. In this regard, the cartridge is in wireless communication715 with an illumination device 717 and other devices 719, for example,a foot pedal, an external console, and/or various status indicatorsassociated with the system. In some embodiments, the handpiece and theinfusion line may also be integrated in a device separate from thecartridge 701, and be in communication with the cartridge via a wirelessconnection. In these embodiments, the cartridge may serve as a wirelesscommunication medium between the devices, including the handpiece andthe infusion line. In embodiments where the cartridge communicates withan external console, the cartridge generally remains independentlyoperable, with the monitor typically serving as a data collection andstorage device. In some embodiments, the external monitor may be capableof serving the system in a larger capacity, for example, by controllingselect instruments of the system. However, in most of these embodiments,the system remains independently functional without the externalconsole.

In the embodiment illustrated in FIG. 7, the cartridge is designed to bea free-standing instrument. In some embodiments, the cartridge includesa ledge 721 on the back that allows the cartridge to be hung off otherequipment inside the sterile field, for example, a surgical tray or Mayotray. In some embodiments, the cartridge includes various components anddevices for controlling the system, for example, a processing unit, usercontrols, a power source 723, and a plurality of different interfacingdevices which may be similar to the processing unit 301, 509, usercontrols 311, 521, and power source 315, 511 of FIGS. 3 or 5. Theinterfacing devices may include, for example, the aspiration chamber andport for a handpiece, the infusion chamber and port for an infusionline, and a wireless communication interface to communicate with theother instruments of the system. The power source provides power to thecartridge and allows the cartridge to function and be poweredindependently of other devices, and in some embodiments, provide powerto connected devices, such as the handpiece. In some embodiments, thecartridge may also include a display and/or speaker, which may outputvarious status indicators or settings of connected instruments.

In some embodiments, the independent surgical center 10 and individualinstruments in the surgical system, including the cartridge, areprepackaged together in sterile packaging. In these embodiments, thepackaging may be opened, and the independent surgical center 10 and theindividual instruments activated, within the sterile operating field,giving a medical practitioner full access to the instruments and usercontrols of the independent surgical center 10 within the sterile field.In some embodiments, upon activation, the cartridge may perform aninitial scan to determine the available devices or instruments withwhich it may establish wireless communication for the surgicalprocedure.

According to one embodiment of the invention, handpiece 711 coupled tothe cartridge 701 includes a biological tissue cutter 725, and may beconnected to the cartridge via a fluid aspiration line 727. Theaspiration line ends in a tip of the handpiece, with the cutter locatedapproximate the tip. User controls located on the cartridge, thehandpiece, and/or the infusion line may be available to adjust theaspiration and infusion levels of the system. Operating parameters forother instruments, for example, illumination level, may be controlleddirectly through the individual devices used to perform each respectivefunction, or may alternatively be controlled at the cartridge if usercontrols for the other instruments are provided to users on thecartridge.

The cartridge may also act as a feedback or user output system. Thecartridge may communicate with the various instruments to retrievestatus information and relay the information to a user of the system. Insome embodiments, information may be displayed on a built-in displaymounted on the cartridge. In other embodiments, other output or userfeedback means may be incorporated, for example, LED indicatorsrepresenting current parameter or status information of the variousinstruments, or audio alerts when, for example, fault levels aretriggered.

FIG. 8 is a block diagram of an independent surgical center embodied asthe infusion/aspiration cartridge 701 of FIG. 7 in accordance with oneembodiment of the invention. In many respects, the structure andfunctionality of the independent surgical center of FIG. 8 are similarto the structure and functionality of the center as discussed in FIG. 5,with a stand-alone aspiration/infusion cartridge substituted into thecenter in place of the tray. The center includes the handpiece 711coupled to the cartridge 701. In the embodiment of FIG. 8, the cartridgeincludes a processing unit and user controls 805, a power source 807, anaspiration device 809, an infusion device 811, and a wirelesstransceiver 813, while the handpiece includes a biological tissue cutter815, as well as its own wireless transceiver 817 and its own powersource 819.

Having different combinations of components housed in each instrumentallows for operational variations between different embodiments. In theembodiment of FIG. 8, for example, the power source in the handpieceprovides power to the rest of the components in the handpiece, allowingthe handpiece to power up independently of the cartridge. A dedicatedpower source therefore obviates the need for a power line runningbetween the cartridge and the handpiece. Furthermore, the wirelesstransceiver housed in the handpiece allows for the handpiece towirelessly communicate 821 with the cartridge, further obviating theneed for an electrical wire or communication line, such as theelectrical line described with respect to FIG. 5. Therefore, in theembodiment of FIG. 8, the only remaining connection between thehandpiece and the cartridge is the aspiration line 727, which transfersaspirated materials from the handpiece back to an aspiration chamber inthe cartridge. In some embodiments, the handpiece may be completelyindependently operable from the cartridge, if an additional aspirationpump and chamber are, for example, located directly on, or closelyattached to, the handpiece. Likewise, with other instruments of thesystem, each independently operable instrument includes a dedicatedpower source, and may also include some wireless communication medium ifcommunication with the processor 805 acting as the main source ofcontrol is desired.

In the embodiment of FIG. 8, the cartridge does not include a monitor orother status indicators. In some embodiments, there may not be anystatus indicators provided by the independent surgical center tocommunicate status information and other useful system information to auser. In other embodiments, different types of status indicators may belocated on one or more instruments remote from the independent surgicalcenter. In some of these embodiments, the status indicators located oneach individual instrument may correspond to, or be otherwise relatedto, the function the instrument serves in the context of the surgicalsystem.

FIG. 9 is a block diagram of yet another alternate embodiment of anindependent surgical center in accordance with one embodiment of theinvention. FIG. 9 may represent a possible alternate componentarrangement for the center of FIG. 7. As has been observed and as wassimilarly described in FIG. 8, the embodiment illustrated FIG. 9includes a handpiece 901 interconnected with a cartridge 903. However,in the embodiment illustrated in FIG. 9, the handpiece serves as aprocessing center of the system instead of the cartridge.

In the embodiment illustrated in FIG. 9, the handpiece includes aprocessing unit and user controls 905, a power source 907, a wirelesstransceiver 909, and a biological tissue cutter 911. The cartridgeincludes a power source 913, an aspiration device 915, and an infusiondevice 917. The processing unit of the handpiece may serve as theprocessing center of the system, and establish communication with thevarious instruments of the system, much like the processing units asdescribed with respect to the tray of FIG. 5 and the cartridge of FIG.8. Alternatively, in some embodiments, a remote instrument of thesystem, for example, an illumination device, may instead house the mainprocessing unit of the system. In the embodiment of FIG. 9, a wirelesstransceiver located in the handpiece is provided for the processing unitto wirelessly communicate with remote instruments of the system. A powersource is further provided to power the handpiece. In some embodiments,the wireless transceiver and power source may alternatively be housed inthe cartridge, to reduce the size of the handpiece and make it easierfor users to handle.

In the embodiment of FIG. 9, the cartridge acts as a supportinginstrument to the handpiece. The user controls for the aspiration deviceand infusion device are located with the processing unit on thehandpiece, but may alternatively be located on the cartridge. Inembodiments where the user controls are located on the handpiece,adjustment requests may be processed by the processing unit on thehandpiece, and adjustment commands generated by the processing unit maybe sent to the appropriate device on the cartridge. The processing unitof the handpiece may also control operating parameters of some remotedevices with which the handpiece is wirelessly connected. In manyembodiments, the processing unit of the handpiece also serves as astatus updater, where status update signals are received by theprocessing unit from various system devices, processed by the processingunit, and communicated to the user of the system, through any of thevarious feedback or output means as have been previously described.

Other embodiments of the invention may include various differentcomponent combinations and functionality differences. For example, thehandpiece may include flow sensors for monitoring aspiration levels atthe surgical site, or aspiration sensors or detectors may instead belocated at or near the aspiration chamber. Further, in some embodiments,an aspiration adjuster or similar device may be located at the handpieceas well, for example, a pinch valve or similar variable orifice. Theaspiration level may be monitored and adjusted by controlling the pinchvalve or orifice diameter. In these embodiments, pressure at theaspiration chamber may be maintained at a constant level. Various otherfeatures may also be incorporated into different instruments of thesystem. For example, the tray or cartridge may include a port foremptying the aspiration chamber and/or a port for filling or refillinginfusion fluid or gas into the infusion chamber. Many other possiblefeatures may be incorporated into the individual instrumentation in eachrespective system.

The different instruments in the independent surgical system as havebeen described are easily portable, require low capital investment, areefficiently set up and torn down, enable the presence of fewer personnelin the operating room, are adaptable for use in existing surgerycenters, and are easily upgradeable. Each instrument is easily moveableinto operating rooms, surgery centers, and offices. A doctor's office isa new potential location where various different procedures may beperformed. In a doctor's office, space is limited, and using largesurgical instrumentation may not always be a realistic option. Thehighly portable instruments of the invention make setting up for variousprocedures faster and more convenient, and may allow for certainprocedures to be performed even in a doctor's office. Portable surgicalsystems may also be used by visiting surgeons, and may potentially betaken to and used in remote locations, such as, for example,economically disadvantaged nations. Along those same lines, theinstruments described are also low in cost. The instruments used in thesystems discussed above are generally all manufactured as disposableunits designed for a single use.

In addition, setup times for the system are vastly reduced. In mostembodiments of the invention, system initialization and communicationestablishment between the different instruments is automatic, and mostinstruments are configured to be immediately ready for use. Connections,for example, an aspiration line running between a handpiece and a trayor cartridge, may be made before packaging, and infusion supplies may beprepackaged for each system. Furthermore, there are generally noadditional wires to connect, and no central console to which eachindividual instrument need be manually connected. Once a procedure hasbeen completed, the instruments may be discarded. In some embodiments,some instruments, for example, aspiration and infusion pumps or devices,may be sent back to a manufacturer for recycling or reuse.

Below are descriptions of other embodiments of a portable biologicaltissue cutter and infusion/aspiration cassette that may functionseparate from the independent surgical center.

Biological Tissue Cutting and Aspiration Handpiece

According to one embodiment, the biological tissue cutting andaspiration handpiece (e.g. vitrectomy handpiece or other likehandpieces) is portable, lightweight and can be powered by battery topower the cutter and/or aspiration. It can be used in the field,offices, surgery centers and operating rooms. The biological tissuecutting and aspiration handpiece may be used as a stand-alone instrumentor in conjunction with the independent surgical center discussed above.The handpiece may be disposable and is connected to theaspiration/infusion cassette, which provides aspiration pressure to thecutter. FIG. 7 illustrates an exemplary aspiration/infusion cassette 701with the infusion line 713 appearing on the right and the biologicaltissue cutting and aspiration handpiece appearing on the left. The leftside of the cassette functions to provide aspiration pressure to thebiological tissue cutting and aspiration handpiece, while the right sideprovides infusion.

In one embodiment, for example, the biological tissue cutting andaspiration handpiece is a disposable handpiece such as that described inco-pending U.S. patent application Ser. No. 11/963,749 entitledDisposable Vitrectomy Handpiece, filed Dec. 21, 2007, the entire contentof which is incorporated herein by reference. In addition, thebiological tissue cutting and aspiration handpiece may incorporatebattery power and a flow controller/pinch valve. The handpiece maywirelessly communicate (e.g. Bluetooth) with other surgical instruments,an internal or external monitor or speaker, or a control center in theaspiration/infusion cassette. Alternatively, the handpiece maywirelessly communicate with a personal surgical center, as described forexample in U.S. Patent Application entitled Personal Surgical Center,filed on even date herewith. Surgical parameters (e.g. cut speed,aspiration pressure/flow rate) may be controlled directly on thehandpiece, or via a foot pedal wirelessly connected to the handpiece.Such parameters may control a cutting tip, aspiration pump, and thelike. The drive circuitry may be incorporated directly in the handpiece,in the surgical tray, or aspiration/infusion cassette depending on howthe handpiece is powered (i.e. by battery or through theaspiration/infusion cassette).

As noted above, according to one embodiment, the biological tissuecutting and aspiration handpiece is a stand-alone instrument, not usedwith an external control center. In this embodiment, the handpiece isused in conjunction with other standalone instrumentation, such as anillumination device. The controls for the handpiece are located on thehandpiece itself, eliminating the need for a surgical console. Thehandpiece itself or the surgical tray may have a display or speaker toinform the surgeon of current surgical settings and instrument faults.According to one embodiment, the handpiece includes a control unit whichmay be, for example, a microprocessor based unit, an ASIC, or the like,and other circuitry described with respect to FIG. 9.

In another embodiment, as also noted above, the biological tissuecutting and aspiration handpiece can be used in conjunction with anaspiration/infusion cassette that includes a control center or inconjunction with an external, laptop control center. Although it may bepossible to plug the system into an outlet, battery power enables bettermaneuverability of the handpiece. The battery may be placed inside thehandpiece, surgical tray or at the aspiration/infusion cassette itself.When the battery is placed inside the handpiece, it adds weight and sizeto the unit, reducing maneuverability and ergonomics. Theaspiration/infusion cassette can be larger and heavier becauseergonomics on this instrument are not as critical. However, when thebattery is placed at the aspiration/infusion cassette or surgical tray,an electrical line would need to be tethered to the handpiece along withthe aspiration line.

The wireless control (e.g. Bluetooth) may be mounted in the handpiece,the aspiration/infusion cassette, the surgical tray or all of the above.This will depend on how the device is configured. If the handpiece usesbattery power and includes no link to the aspiration cassette orsurgical tray, wireless communication will need to be mounted on allunits. However, if there is a direct-wired link between the two,wireless communications may then be mounted on either unit. In oneembodiment, the wireless communication will be mounted on theaspiration/infusion cassette or surgical tray to reduce the weight ofthe handpiece. FIG. 5 illustrates a system in which the battery powerfor the biological tissue cutting and aspiration handpiece, the wirelesscommunication and the aspiration all originate from the surgical tray.

As noted above, the handpiece may include a display or speaker forrelaying information regarding instrument status, fault, cut speed etc.For example, the handpiece may include a LED or speaker on the handpieceitself. Alternatively, the instrument and operation information may beindicated on a display or speaker on the surgical tray or may bedisplayed on a laptop center.

When used in conjunction with a laptop center, the biological tissuecutting and aspiration handpiece may communicate with the laptopdirectly or indirectly through the surgical tray. The laptop center canindicate the instrument and operation information, such as current cutspeed, battery life (if applicable), and any faults. It may also receiveadditional information, such as the maximum cut speed permissible andother surgical parameters. Upon startup, the biological tissue cuttingand aspiration handpiece can identify itself to the laptop center andindicate whether it has been used before.

If flow sensing or flow control is used, the sensors and actuators maybe placed close to or directly on the biological tissue cutting andaspiration handpiece.

Aspiration/Infusion Cassette

According to one embodiment, the aspiration/infusion cassette isportable, lightweight, and attached to a biological tissue cutting andaspiration handpiece and infusion line. According to one embodiment, theaspiration/infusion cassette is made integral with the surgical tray,but according to one embodiment, the cassette is separate from the tray.In this latter embodiment, the cassette includes a control unit whichmay be, for example, a microprocessor based unit, an ASIC, or the like,and other circuitry described with respect to FIG. 8 which allows thecassette be the center of control with respect to the cassette and/orthe biological tissue cutting device.

The cassette may be used in the field, offices, surgery centers andoperating rooms. The cassette may be used as a stand-alone instrument orin conjunction with a surgical center, such as the one discussed above.Alternatively, the cassette may be used in conjunction with a personalsurgical center, such as that described in co-pending U.S. PatentApplication entitled Personal Surgical Center filed on even dateherewith.

The aspiration/infusion cassette includes infusion fluid (such as BSS)and an aspiration line. Aspiration is applied to a portable surgicalhandpiece, such as the biological tissue cutting and aspirationhandpiece described above. Infusion is attached to an infusion line. Inone embodiment, the aspiration/infusion cassette includes a cassette forgas-fluid exchange system. Additionally, there may be ports to allowfilling the BSS container (if required) or emptying the aspirationcassette. Furthermore, from the filling port, a surgeon may put inglucose or other medication (e.g. dyes for visualization) for certaincases into the infusion cassette.

When the aspiration/infusion cassette is used in conjunction with apersonal surgical center, it is powered separately from the center.Although it may be possible to plug the system into an outlet power,battery power enables better maneuverability. The battery can be placedin the cassette itself or in the surgical tray, and powers any vacuum orinfusion pumps as well as the biological tissue cutting and aspirationhandpiece. Power to the cassette can be turned on once the cassette orsurgical tray is removed from the packaging (e.g. by turning on aswitch, button, etc.). This will initiate communication with thepersonal surgical center, if present.

In one embodiment, the aspiration/infusion cassette is a free-standinginstrument. The vacuum source may be directly mounted on the cassetteitself. It may be a vacuum based system, similar to the venturi system,or a flow based system (peristaltic pump). Any suitable vacuum basedsystem may be used, for example, the vacuum source may consist of asmall, battery-powered vacuum pump providing vacuum pressure to thehandpiece. Alternatively, the vacuum source may be a motor controlling asyringe/piston or pump to apply vacuum pressure. The vacuum source mayprovide a constant vacuum level, charging only when required, or it mayallow for variable vacuum settings. For flow based vacuum, a smallelectric pump is added to the cassette instead of the peristaltic pump.

The aspiration/infusion cassette communicates with the personal surgicalcenter (when present) via a wireless link. When no center is used, thecassette may communicate wirelessly with other instrumentation, such asthe biological tissue cutter or illumination handpiece.

The cassette may also include a pre-packaged vacuum source, which wouldbe shipped as an evacuated container. To use, the seal is broken, andthe vacuum is applied to the handpiece. However, if vacuum is lost, thecassette cannot be re-charged.

Flow control for aspiration can be controlled from the surgicalhandpiece. The flow control may be on the handle or on a foot pedalwhich may be wirelessly connected. Infusion control may be on thesurgical handpiece, on a foot pedal, controlled by an IV pole height, orby a switch on the aspiration/infusion cassette itself.

Vacuum at the cassette may be constant or variable. With variable vacuumlevel control, the level of vacuum is modified based on surgicalsettings. Vacuum is directly attached to the vitrectomy aspiration line,and flow is based on vacuum level.

If vacuum is maintained constant at the cassette, a pinch valve/variableorifice may be used to modulate flow. In this scenario, full vacuumwould be maintained in the cassette and applied for substantially all ofthe time to the back of the aspiration line. The pinch valve would beused to modulate the flow level. A pressure sensor could be mountedupstream (closest to the biological tissue cutting and aspirationhandpiece) from the pinch valve. This would monitor the actual pressureand permit accurate pinch valve settings in a continuous manner. A flowsensor may be used to measure flow rate instead of the pressure sensor.Flow can be modulated by adjusting the pinch valve. In either scenario,surging would be reduced by monitoring flow close to the handpiece. Fora flow based system, the surgeon would control the rate at which thevacuum pump removes tissue from the eye. Flow may be monitored by asensor at the cassette or at the surgical instrument handpiece. Thiscould be used for feedback on the flow conditions.

Infusion can be applied from a small disposable pump, a Harvard typeapparatus mechanism, a spring loaded syringe, small fluid pump, or bymounting the unit on an IV pole. A pre-packaged amount of sterilebalanced salt solution (BSS) is provided for the procedure. The volumeof BSS is the same as or smaller than the volume of the aspirationcassette.

If a disposable pump is used in the cassette, it may pressurize thecassette causing the BSS to enter the eye. A filter may be required tokeep the inside of the infusion cassette free of airborne particles.Alternatively, a small sealed infusion bag may be mounted to theinfusion line. The chamber around the infusion line is pressurized,causing the infusion fluid to enter the eye and not come in directcontact with the pressurized air. A peristaltic pump may also be used toinfuse the eye. Alternatively, a Harvard type apparatus or springcompressed syringe may be used to infuse the BSS.

If an IV pole is used, the cassette could hang from many different IVpole designs. Furthermore, a specific IV pole may be designed to workwith the cassette. In this scenario, there would be a place for thecassette to fit and the IV pole may provide power for the aspirationpump. No infusion pump would be required for maintaining eye pressure.

As noted above, the aspiration/infusion module may communicate with apersonal surgical center if such a center is used. It will send statusinformation regarding the state of the instruments, and receiveinformation that may change operable parameters. Once theaspiration/infusion cassette is turned on, it will communicate with thepersonal surgical center to indicate serial number, if it has been usedbefore, and the type of instrumentation being used (25 versus 23-gaugeinstrumentation), which vitrectomy probe is being used, etc. Thecassette can also communicate the status of the battery and anyinstrument faults that may occur.

A wireless control may be mounted on the biological tissue cutting andaspiration handpiece, the aspiration/infusion cassette, illuminator,surgical tray, or all of the above. This will depend on how the deviceis configured. If the biological tissue cutting and aspiration handpieceuses battery power and is not directly linked to the aspirationcassette, wireless communication is mounted on both units. If there is adirect wired link between the two, wirelesses communication may bemounted on either unit, but need not be mounted on both units. In oneembodiment, the wireless communication is mounted on the cassette toreduce the weight of the handpiece.

The aspiration/infusion cassette may include a chamber for gas-fluidexchange in the eye. This could be a syringe filled with the appropriategas or mixture of gases. A Harvard type apparatus, spring mechanism, orpump could also be used to administer gas-fluid exchange. The gas linewould be connected to the infusion line. A remote switch could be usedto commence gas exchange. The button for this may be on the illuminationdevice, surgical tray, the biological tissue cutting and aspirationhandpiece, or any other suitable location. The specific gases useddepend on the specific procedures performed.

Instrument settings, operational parameters, and status may be displayedon the aspiration/infusion cassette itself. Alternatively, thisinformation can be directed to and displayed on the independent surgicalcenter, the cassette, or on the personal surgical center connected(either directly or wirelessly) to the cassette. In another embodiment,the information is displayed on an external monitor or through a speakerconnected (either directly or wirelessly) to the cassette. Theinformation displayed may include bottle infusion pressure, cut speedfor the vitrectomy probe, fault conditions, conditions of batteries, andother operational parameters.

The cassette may include a ledge on the back of the cassette that allowsthe cassette to be hung off the surgical tray. Alternatively, thecassette is incorporated into the tray. The aspiration and infusionpump(s) and battery may be separate from the aspiration/infusioncassettes, allowing the surgeon to break off the aspiration and infusioncassettes after the procedure and dispose of them. The pump or batterycomponent may be refurbishment and then re-deployed.

Although the invention has been described with respect to certainspecific embodiments, those skilled in the art will have no difficultydevising variations to the described embodiments which in no way departfrom the scope and spirit of the present invention. Furthermore, tothose skilled in the various arts, the invention herein may suggestsolutions to other tasks and adaptations for other applications. It isthe Applicants' intention to cover all such uses of the invention, andthose changes and modifications which could be made to the embodimentsof the invention herein chosen for the purpose of disclosure withoutdeparting from the spirit and scope of the invention. Thus, the presentembodiments of the invention should be considered in all respects asillustrative and not restrictive.

1. An independent system for a surgical procedure comprising: a controldevice including a processing unit; and a plurality of instrumentsassociated with the surgical procedure and operably couple t do thecontrol device, wherein the control device and the plurality ofinstruments are prepackaged together, and the processing unit isconfigured to control at least one of the prepackaged instruments. 2.The system of claim 1, wherein the control device is a surgical tray. 3.The system of claim 1, wherein the instruments are electrical orpneumatic instruments associated with the surgical procedure.
 4. Thesystem of claim 1, wherein the surgical procedure is an ophthalmicsurgical procedure.
 5. The system of claim 1, wherein the surgicalprocedure includes biological tissue cutting and fluid aspiration. 6.The system of claim 1, wherein at least one of the plurality ofelectrical instruments includes a processing unit.
 7. The system ofclaim 6, wherein the processing unit is configured to establishcommunication between each of the plurality of electrical instruments.8. The system of claim 7, wherein the communication is wirelesscommunication.
 9. The system of claim 7, wherein the processing unit isfurther configured to: receive status updates from the plurality ofelectrical instruments; and communicate with status updates to a user ofthe system.
 10. The system of claim 6, wherein the at least one of theplurality of electrical instruments includes user controls for adjustingthe operating parameters of at least one other of the plurality ofelectrical instruments.
 11. The system of claim 6, wherein the at leastone of the plurality of electrical instruments is a surgical tray. 12.The system of claim 1, wherein each of the plurality of electricalinstruments sterile and useable within a sterile barrier during thesurgical procedure.
 13. The system of claim 1, wherein the plurality ofelectrical instruments are prepackaged together in a sterile packaging.14. A surgical system comprising: a portable surgical tray including aprocessing unit; a plurality of instruments operably coupled to theprocessing unit; and a user input device providing a user input forcontrolling an operating parameter of one or more of the plurality ofinstruments, wherein the processing unit is configured to receive theuser input and transmit an operating command to the one or more of theof the plurality of instruments.
 15. The system of claim 14, wherein theplurality of instruments includes a biological tissue cutter and anaspiration device.
 16. The system of claim 15, wherein an aspirationline connects the biological tissue cutter and an aspiration device. 17.The system of claim 15, wherein the plurality of instruments furtherincludes an infusion device.
 18. The system of claim 14, wherein theplurality of instruments includes an illumination device.
 19. The systemof claim 14, wherein the user controls controlling the operatingparameters of a one of the plurality of instruments is located on theone of the plurality of instruments.
 20. The system of claim 14, whereinthe plurality of instruments includes a surgical tray including aprocessing unit, the processing unit configured by program instructionsto: receive an adjustment signal from the user controls; and adjust theoperating parameters of a one of the plurality of instruments based onthe adjustment signal.
 21. A self-powered surgical system for a surgicalprocedure, comprising: a surgical tray; a plurality of handheldinstruments; a power source in at least one of the surgical tray and ahandheld instrument; and a processing unit; wherein the processing unitis configured to execute program instructions, the program instructionsincluding instructions for: detecting power from the at least one powersource; directing power to the plurality of handheld instruments fromthe at least one power source; and establishing communication with eachof the plurality of handheld instruments.
 22. The system of claim 21,wherein the program instructions further include instructions for:receiving an adjustment request for a one of the plurality of handheldinstruments; and adjusting operating parameters of the one of theplurality of handheld instruments based on the adjustment request. 23.The system of claim 22, wherein each adjustment request is received froma one of the plurality of handheld instruments.
 24. The system of claim21, wherein the processing unit is housed in the surgical tray.
 25. Thesystem of claim 24, wherein the plurality of handheld instruments andthe at least one power source are packaged with the surgical tray priorto the surgical procedure.
 26. The system of claim 25, wherein thepackage is sterile.
 27. The system of claim 26, wherein each of theplurality of handheld instruments is useable within a sterile barrierduring the surgical procedure.
 28. The system of claim 26, wherein theplurality of handheld instruments are configured to be used within asubstantially sterile barrier during the surgical procedure and arefurther configured to be accessed by a substantially non-sterileassistant.
 29. The system of claim 21, wherein at least one of theplurality of handheld instruments is physically connected to thesurgical tray.
 30. The system of claim 21, wherein the programinstructions further include instructions for: receiving a status updatesignal from a one of the plurality of handheld instruments; andadjusting a status indicator associated with the one of the plurality ofhandheld instruments based on the status update signal.
 31. The systemof claim 21, wherein the processing unit is housed in one of theplurality of handheld instruments.
 32. The system of claim 21, whereineach of the plurality of handheld instruments includes a radio frequencyidentification tag to facilitate establishment of communication with theprocessing unit.
 33. A portable biological cutting and aspiration devicecomprising: a cutting tip; a fluid aspiration device; and an integratedcontrol unit coupled to the cutting tip and fluid aspiration device,wherein the control unit is configured to control cutting and aspirationof the cutting tip and fluid aspiration device.
 34. A portable infusionand aspiration device comprising: an aspiration chamber; an aspirationline coupled to a biological tissue cutting and aspiration device, theaspiration line configured to suction matter dislodged from a surgicalsite into the aspiration chamber; an infusion chamber having an infusionsolution; an infusion line coupled to the infusion chamber andconfigured to inject the infusion solution to the surgical site formaintaining pressure in the surgical site, wherein the aspirationchamber and infusion chamber are included in a single, disposablecassette.